Endoscopy, GastrointestinalNCT06218017
Development of an Algorithm to Denoise HFNO-generated Tracheal Sound
A study testing High flow nasal oxygen fist and High flow nasal oxygen later in people with Endoscopy, Gastrointestinal and Sedation, Conscious, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Gastrointestinal, Sedation, Conscious
- What is being tested?
- High flow nasal oxygen fist and High flow nasal oxygen later
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation
Who cannot join
- Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor
- Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Tawain University Hospital Hsinchu branch
Hsinchu, 300
Chun-Yu Wu, 800-555-5555, b001089018@tmu.edu.tw
Tsung-Da Wu, 800-555-5555, tsungta.wu@gmail.com
- Recruiting
National Tawain University Hospital Hsinchu branch
Hsinchu, 300
Chun-Yu Wu, 800-555-5555, b001089018@tmu.edu.tw
Tsung-Da Wu, 800-555-5555, tsungta.wu@gmail.com
About this study
Official title: Development of Algorithm to Precise Monitoring Respiratory Sound During Deep Sedation Using the High Flow Nasal Oxygen System
This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.
Read the detailed description
During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.
- Conditions
- Endoscopy, Gastrointestinal, Sedation, Conscious
- Being tested
- High flow nasal oxygen fist, High flow nasal oxygen later
- Keywords
- Tracheal sound, Electronic auscultation, High flow nasal oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygen fistDevice
Patients in the two study group first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min) or underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min).
High flow nasal oxygen laterDevice
Patient in this group underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min)
| Study group | Role | What they receive |
|---|---|---|
| HFNO first | Experimental | This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen. Receives: Device: High flow nasal oxygen fist |
| HFNO later | Active comparator | This study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen Receives: Device: High flow nasal oxygen later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise
We aim to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen based on recording the tracheal sound of patients undergoing gastrointestinal endoscopy in deep sedation with and without high flow nasal oxygen
Measured: 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy, GastrointestinalStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218017
- Sponsor's protocol ID
- 202310040DINC
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared by contacting the principle investigator for rational research purpose.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Algorithm to Precise Monitoring Respiratory Sound During Deep Sedation Using the High Flow Nasal Oxygen System
- ClinicalTrials.gov ID
- NCT06218017
- Acronym / sponsor ID
- 202310040DINC
- Conditions
- Endoscopy, Gastrointestinal, Sedation, Conscious
- Keywords
- Tracheal sound, Electronic auscultation, High flow nasal oxygen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.
Detailed description
During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNO first | Experimental | Device: High flow nasal oxygen fistThis study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen. |
| HFNO later | Active comparator | Device: High flow nasal oxygen laterThis study follows a crossover design employing a randomized controlled methodology. Patients undergoing gastrointestinal endoscopy and receiving deep sedation were monitored using electronic tracheal sound auscultation. Within this group, patients first underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min). Electronic tracheal sound recordings were obtained during both the high-flow and low-flow nasal oxygen administrations. The aim is to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation
Key exclusion criteria (2 listed)
- Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor
- Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal oxygen fistPatients in the two study group first underwent a 10-minute session of high-flow nasal oxygen (50 L/min) followed by the utilization of the standard low-flow nasal oxygen (4 L/min) or underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min). | Device | HFNO first |
| High flow nasal oxygen laterPatient in this group underwent a 10-minute session of standard low-flow nasal oxygen (4 L/min) followed by the utilization of the high-flow nasal oxygen (50 L/min) | Device | HFNO later |
Primary outcome
Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise
Time frame: 20-30 minutes
We aim to develop an algorithm capable of mitigating the noise generated specifically by the high-flow nasal oxygen based on recording the tracheal sound of patients undergoing gastrointestinal endoscopy in deep sedation with and without high flow nasal oxygen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Yes. The IPD will be shared by contacting the principle investigator for rational research purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen fist and High flow nasal oxygen later in people with Endoscopy, Gastrointestinal and Sedation, Conscious, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Wu, MD (800-555-5555, b001089018@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise (time frame: 20-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.